Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/103251
Citations | ||
Scopus | Web of Science® | Altmetric |
---|---|---|
?
|
?
|
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Pal, S. | - |
dc.contributor.author | Azad, A. | - |
dc.contributor.author | Bhatia, S. | - |
dc.contributor.author | Drabkin, H. | - |
dc.contributor.author | Costello, B. | - |
dc.contributor.author | Sarantopoulos, J. | - |
dc.contributor.author | Kanesvaran, R. | - |
dc.contributor.author | Lauer, R. | - |
dc.contributor.author | Starodub, A. | - |
dc.contributor.author | Hauke, R. | - |
dc.contributor.author | Sweeney, C. | - |
dc.contributor.author | Hahn, N. | - |
dc.contributor.author | Sonpavde, G. | - |
dc.contributor.author | Richey, S. | - |
dc.contributor.author | Breen, T. | - |
dc.contributor.author | Kremmidiotis, G. | - |
dc.contributor.author | Leske, A. | - |
dc.contributor.author | Doolin, E. | - |
dc.contributor.author | Bibby, D. | - |
dc.contributor.author | Simpson, J. | - |
dc.contributor.author | et al. | - |
dc.date.issued | 2015 | - |
dc.identifier.citation | Clinical Cancer Research, 2015; 21(15):3420-3427 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.issn | 1557-3265 | - |
dc.identifier.uri | http://hdl.handle.net/2440/103251 | - |
dc.description.abstract | Purpose: BNC105P inhibits tubulin polymerization, and preclinical studies suggest possible synergy with everolimus. In this phase I/II study, efficacy and safety of the combination were explored in patients with metastatic renal cell carcinoma (mRCC). Experimental Design: A phase I study in patients with clear cell mRCC and any prior number of therapies was conducted using a classical 3 + 3 design to evaluate standard doses of everolimus with increasing doses of BNC105P. At the recommended phase II dose (RP2D), patients with clear cell mRCC and one to two prior therapies (including ≥1 VEGF-TKI) were randomized to BNC105P with everolimus (arm A) or everolimus alone (arm B). The primary endpoint of the study was 6-month progressionfree survival (6MPFS). Secondary endpoints included response rate, PFS, overall survival, and exploratory biomarker analyses. Results: In the phase I study (N = 15), a dose of BNC105P at 16 mg/m² with everolimus at 10mg daily was identified as the RP2D. In the phase II study, 139 patients were randomized, with 69 and 67 evaluable patients in arms A and B, respectively. 6MPFS was similar in the treatment arms (arm A: 33.82% vs. arm B: 30.30%, P = 0.66) and no difference in median PFS was observed (arm A: 4.7 mos vs. arm B: 4.1 mos; P = 0.49). Changes in matrix metalloproteinase-9, stem cell factor, sex hormone-binding globulin, and serum amyloid A protein were associated with clinical outcome with BNC105P. Conclusions: Although the primary endpoint was not met in an unselected population, correlative studies suggest several biomarkers that warrant further prospective evaluation. | - |
dc.description.statementofresponsibility | Sumanta Pal ... Christopher J. Sweeney ... et al. | - |
dc.language.iso | en | - |
dc.publisher | American Association for Cancer Research | - |
dc.rights | ©2015 American Association for Cancer Research. | - |
dc.source.uri | http://dx.doi.org/10.1158/1078-0432.ccr-14-3370 | - |
dc.subject | Humans | - |
dc.subject | Carcinoma, Renal Cell | - |
dc.subject | Benzofurans | - |
dc.subject | Sex Hormone-Binding Globulin | - |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | - |
dc.subject | Disease-Free Survival | - |
dc.subject | Treatment Outcome | - |
dc.subject | Adult | - |
dc.subject | Aged | - |
dc.subject | Aged, 80 and over | - |
dc.subject | Middle Aged | - |
dc.subject | Female | - |
dc.subject | Male | - |
dc.subject | Matrix Metalloproteinase 9 | - |
dc.subject | Kaplan-Meier Estimate | - |
dc.subject | Organophosphates | - |
dc.subject | Everolimus | - |
dc.title | A phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-14-3370 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Sweeney, C. [0000-0002-0398-6018] | - |
Appears in Collections: | Aurora harvest 3 Medicine publications |
Files in This Item:
There are no files associated with this item.
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.